EU GMP Annex 1, Section 3 - Quality Risk Management

What it says

Quality Risk Management principles must be formally and systematically applied to identify, assess and control contamination risks across the sterile manufacturing facility, with risk assessments kept current, proportionate to actual risk, and directly informing the decisions reflected in the site's Contamination Control Strategy.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This section requires risk management to be genuinely systematic, a documented methodology applied consistently, rather than an informal judgment call made differently by different people reviewing similar risks.
• Risk assessments under this section are expected to directly drive real decisions, facility design, monitoring frequency, personnel practices, not exist as a parallel paperwork exercise disconnected from how the site actually operates.
• Because contamination risk changes over time as equipment ages, personnel turn over or processes evolve, risk assessments performed under this section need periodic review, not a one-time assessment frozen at the time of facility qualification.

What inspectors look for

• Whether a documented, systematic Quality Risk Management methodology is actually applied to contamination control decisions, rather than informal or inconsistent risk judgments.
• Whether risk assessment conclusions are traceable to specific facility design, monitoring or process control decisions that were actually implemented.
• Whether risk assessments are reviewed and updated periodically, particularly after equipment changes, personnel changes or monitoring excursions.

Related regulations